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FDA 510(k)

TOTAL HIGE ENZYME IMMUNOASSAY

K-Number: K850786 · 1985-04-12

ApplicantNms Pharmaceuticals, Inc.
Decision Date1985-04-12
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TOTAL HIGE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Nms Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1985-04-12 under 510(k) number K850786. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL HIGE ENZYME IMMUNOASSAY?

TOTAL HIGE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1985-04-12. The listed applicant is Nms Pharmaceuticals, Inc.. The 510(k) number is K850786.

When did TOTAL HIGE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

TOTAL HIGE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1985-04-12, under 510(k) number K850786.

Who is the listed applicant for TOTAL HIGE ENZYME IMMUNOASSAY?

The FDA 510(k) record lists Nms Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL HIGE ENZYME IMMUNOASSAY?

The FDA product code for TOTAL HIGE ENZYME IMMUNOASSAY is DGC.

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Other records listing Nms Pharmaceuticals, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K861202TRU-LEVEL CONTROL IMMUNOASSAY CONTROLSK854236HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDSK860828FORETEL, COLOR OVULATION TESTK853925QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISAK851445COLOR OVULATION TESTK850431EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL

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Related Devices (Code: DGC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231151Kenota 1 Total IgE; Kenota 1 (instrument)Kenota, Inc.K214068Quantia IgEBiokit, S.A.K220178Total Immunoglobulin E (IgE)Beckman Coulter, Inc.K193493ADVIA Centaur Total IgE (tIgE)Siemens Healthcare Diagnostics, Inc.K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia ABK063425DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGHDade Behring, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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